Customer Understanding

Customer profile

Small European based Research and Development company intending to develop and register their first NCE targeting Non-Alcoholic Fatty Liver Disease (NAFLD) & Steatohepatitis (NASH).
This drug was not authorised anywhere in the world.

Customer Challenges

  • Due to the size and nature of the company, they possessed expertise in drug development, but has very little expertise in pre-clinical and clinical regulations.
  • Initial data collected had not been validated against the latest regulations for compliance.
  • Lack of experience in selecting Clinical Research Organisation (CRO) for pre-clinical & clinical studies.
  • Client did not have an in house pre-clinical & clinical expert to design a development plan for required studies.
  • Client had limited ability to manage all the necessary studies and data analysis required for pre-clinical and clinical requirements.

PLG’s Responsibilities & Activities

Scope of work provided:

Due Diligence

  • With the client’s existing data, PLG conducted a due diligence identifying possible gaps that could exist.
  • PLG conducted robust Literature searches using regulatory requirements and similar product types to create a development plan for the product. Inclusive of Good Lab and Clinical Research Practices (GLP & GCP).

Product Development

  • Leveraging on the development created, PLG initiated contact with several CROs on behalf of the client to select the appropriate candidate to carry out the pre-clinical studies.
  • Currently PLG is managing on behalf of the client the 180 days toxicity project with upcoming studies including; 28 days repeat dose toxicity, Safety Pharmacology, Metabolite Profiling, PK Studies & Genotoxicity

Solution provided by PLG

The client received:

  • A team or highly skilled and experienced pre-clinical & clinical experts to assess current data & design development plans.
  • Qualification & Selection for CRO to conduct studies.
  • A robust Project Management plan with allocated milestones to keep the project on track.
  • In conjunction with the above SMEs, a dedicated Project Management team to assist in the collection of study data and keeping the client in constant communication for timely updates.

Added-value and customer benefits

Added-value

  • Specific Subject Matter Expert resources dedicated to the client’s project. A cost-effective solution with centralized project management & offshore operational resources.
  • KPIs: 100% correspondence vs. manual processes. 80-90% reduction in the manpower needed

PLG success factors

  • Flexibility in working with the client’s preferred schedule of payment.
  • PLG’s wholistic understanding of the client’s “wants and needs”, while managing the client’s realistic expectations.

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Clinical Trials: Due Diligence, Strategy & Study Management for NCE in EU